Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

The enrollment period was 3/14/06 - 6/13/08. Subjects were recruited from academic & private clinics in the US. Two groups of subjects were eligible for enrollment in this study. Subjects were eligible to enter this study following completion of the placebo-controlled study, FEN-201 or they were enrolled directly into this study.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Open Label Fentanyl Treatment

BioErodible Muco Adhesive(BEMA) Fentanyl

Baseline Measures

Open Label Fentanyl Treatment

Number of Participants
[units: participants]

243

Age
[units: participants]

<=18 years

0

Between 18 and 65 years

168

>=65 years

75

Age
[units: years]Mean (Standard Deviation)

58.0
(12.12)

Gender
[units: participants]

Female

128

Male

115

Race (NIH/OMB)
[units: Participants]

American Indian or Alaska Native

0

Asian

2

Native Hawaiian or Other Pacific Islander

0

Black or African American

23

White

209

More than one race

0

Unknown or Not Reported

9

Region of Enrollment
[units: participants]

United States

243

Outcome Measures

1. Primary:

Percentage of Participants With Adverse Events. [ Time Frame: Participants were followed for the duration of the study, an average of 126 days ]

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.